BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENHANCED METER

    MDR report key: 1243807 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03230
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 16, 2008
    Report Date
    November 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH BASIC METER WOULD NOT POWER ON. THE PATIENT TESTS HIS BLOOD GLUCOSE TWICE A DAY. HE TESTS BEFORE BREAKFAST AND AT BEDTIME. THE PATIENT TAKES METFORMIN AND JANUVIA. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED THREE DAYS PRIOR, AT AN UNSPECIFIED TIME. ALTHOUGH THE PATIENT CLAIMED THAT HE WAS UNABLE TO TEST HIS THAT DAY, HE CONTINUED TO TAKE HIS MEDICATIONS AS PRESCRIBED. AT UNSPECIFIED TIMES LATER THAT SAME DAY, THE PATIENT ALLEGED THAT HE DEVELOPED SYMPTOMS OF FEELING LOW BECAUSE OF THE METER ISSUE. HE WAS UNABLE TO SPECIFY WHAT ACTUAL SYMPTOMS HE HAD. AS A RESULT OF DEVELOPING THE SYMPTOMS, THE PATIENT ADMINISTERED SELF-CARE BY EATING FOOD AND DRINKING A BEVERAGE WHICH HELPED TO RELIEVE HIS SYMPTOMS. THE ALLEGED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THE COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS OF HYPOGLYCEMIA AFTER THE ALLEGED METER STOPPED POWERING ON. IT IS UNCLEAR AS TO WHAT SPECIFIC SYMPTOMS HE HAD. HOWEVER, HE MENTIONED THAT HE TREATED HIMSELF BY CONSUMING FOOD/DRINK(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening